Visera Hysterovideoscope Olympus HYF Type V— 510(k) K221557

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K221557 for Visera Hysterovideoscope Olympus HYF Type V, Substantially Equivalent on 2022-09-02. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2022-05-31
Decision date: 2022-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.